In a cohort study of nearly 80,000 patients, 92% were given IV steroids and only 8% were initially treated with low-dose oral medications as guidelines urge, according to Peter Lindenauer, MD, of Baystate Medical Center in Springfield, Mass., and colleagues.

But the risk of treatment failure with low-dose steroids was no greater, and costs were lower and hospital stays were shorter, the researchers reported in the June 16 issue of the Journal of the American Medical Association.

The findings have a "significant potential to alter practice, potentially reducing costs, complications, and lowering the risks of steroid-associated adverse events," the researchers concluded.

Clinical trials have shown that systemic corticosteroids improve outcomes in patients who need inpatient care for exacerbations of COPD, which amounted to about 600,000 admissions in 2006. But the best dose and route of administration remains uncertain, although clinical guidelines from professional societies in Europe and the U.S. suggest low-dose oral medications.

To help fill the gap, the researchers conducted a pharmacoepidemiological cohort study using registry data from 414 U.S. hospitals and involving 79,985 patients admitted with acute exacerbation of COPD in 2006 and 2007 who received systemic corticosteroids during the first two hospital days.

The primary outcome was treatment failure, defined as a composite including initiation of mechanical ventilation after the second hospital day, inhospital death, or readmission for COPD exacerbation within 30 days of discharge.

Because mechanical ventilation was part of the endpoint, patients admitted directly to intensive care were excluded from the analysis.

The analysis showed that 73,765 patients were initially treated with intravenous steroids and 6,220 received oral treatment.

But there was no statistical difference in results: 10.9% of the IV-treated and 10.3% of the orally treated patients experienced the composite outcome and the 95% confidence intervals overlapped.

After multivariable adjustment, including the propensity for oral treatment, the risk of treatment failure still did not differ significantly: The odds ratio was 0.93, with a 95% confidence interval from 0.84 to 1.02.

On the other hand, in a propensity-matched analysis, the risk of treatment failure was lower among orally treated patients (OR 0.84, 95% CI 0.75 to 0.95), as were length of stay and cost, the researchers said.

Lindenauer and colleagues said the intravenous approach "does not appear to be associated with any measurable clinical benefit and at the same time exposes patients to the risks and inconvenience of an intravenous line, potentially unnecessarily high doses of steroids, greater hospital costs, and longer lengths of stay."

They cautioned that the study is observational and noted that a major limitation is that it excluded patients admitted directly to intensive care and so can't be generalized to all patients.

On the other hand "the data are sufficient to take action to change practice now," argued Jerry Krishnan, MD, PhD, of the University of Chicago, and Richard Mularski, MD, of Kaiser Permanente and Oregon Health and Science University in Portland.

"Caution should be exercised when advocating a change in clinical practice based on observational research," they said in an accompanying editorial, but the other way forward -- a clinical trial comparing the two approaches -- would require too many patients and take too long to be practical.

On the other hand, they said, "given that current practice overwhelmingly favors high-dose intravenous corticosteroids, facilitating change will be daunting."

Premier Healthcare Informatics of Charlotte, N.C., provided the data used in the study but, otherwise, it was conducted without external funding.

Neither the researchers nor the editorialists made any financial disclosures relevant to the study.

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